Inflammation Clinical Trial
Official title:
Semaglutide Treatment for PRevention Of Toxicity in High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
The primary objective of this clinical trial is to ievaluate the effect of semaglutide (GLP-1 receptor agonist) in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) haematopoietic stem cell transplantation (HSCT). The secondary objective is to evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT. Study design: The study is designed as a randomized, double-blind, placebo-controlled, phase 2, two-centre investigator-initiated clinical study. Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 1:1 manner to receive either semaglutide or placebo. The study includes a run-in period 3 to 4-week low-dose period with semaglutide subcutaneously (s.c.) 0.25 mg once-weekly (QW) prior to high-dose chemotherapy treatment followed by a period of 4 to 5 weeks with semaglutide 0.5 mg QW. Total duration of treatment with investigational drug will be 8 weeks. Total study duration for the individual patients will be 20-22 weeks, including a 2-4-week screening period and 10 weeks of follow-up. Study population: A planned total number of 40 patients will be randomized.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
| Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
| Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
| Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
| Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
| Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
| Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
| Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
| Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
| Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
| Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
| Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
| Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
| Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
| Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
| Not yet recruiting |
NCT06422494 -
The Role of the Adrenergic System in Hypoglycaemia Induced Inflammatory Response in People With Type 1 Diabetes and People Without Type 1 Diabetes-RAID-II
|
N/A |